www.ema.europa.eu At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and...

www.ema.europa.eu EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This...

www.ema.europa.eu EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).Evidence from more than 13 billion doses of COVID-19 vaccines administered worldwide shows that these vaccines aimed...

www.ema.europa.eu Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent...

www.ema.europa.eu Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting.The committee recommended granting a marketing authorisation for Aquipta (atogepant), intended for the prophylaxis of migraine...

www.ema.europa.eu The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA)...